Model Number 201-30105 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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It was reported that there was a flow of 0.47 lpm when the centrimag (cmag) system was not turned on and there is no flow.The cmag flow probe was connected to a backup cmag system, and the problem continued.The flow probe was then switched with the a different flow probe with the same console.This resolved the issue.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the reported event of the flow probe measuring flow when the motor isn¿t running was confirmed.The centrimag flow probe was returned for analysis to the edc and was evaluated.The reported event was able to be reproduced.The flow probe was tested with two different consoles.When the motor was not running, 0 rpm, the flow readings were always between 0.40 lpm ¿ 0.48 lpm.The flow probe is out of calibrations and will be scrapped.The root cause for the reported event was conclusively determined to be due to the flow probe needing calibration.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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